Operating Procedures for Individual Financial Conflicts of Interest

These procedures support the policy on Individual Financial Conflicts of Interest (III.B.2). Refer to the policy for contact information and definitions.

Effective date: January 8, 2024

Submitting Disclosures
Review of Disclosures
Notices to Employees
Training Requirements
Appeals
History and Updates
Appendix A: Specified Sponsors

Submitting Disclosures

University Contracts, Purchases and Procurement
1. Who: Employees who have a Financial Interest in a University purchase, procurement of goods or services, contract, investment, and/or loan. The Financial Interest may be held in any of the following ways:
  1. By the Employee.
  2. By a Dependent of the Employee.
  3. Through an interest in or relationship with a vendor or other entity.
2. What: Submit a Conflict of Interest Disclosure Statement (PDF) to the COI Officer.
  1. Electronically to compliance@purdue.edu.
  2. Via campus mail to the COI Officer, Young Hall, room 1029.
3. When: Disclosures must be made as far in advance of the purchase, procurement, investment, etc., as possible to provide sufficient time for approval of the disclosure in a public meeting of the Board of Trustees. Thereafter, submit a disclosure statement annually for any continuing Financial Interests.
  
  In cases where a University committee on which the Employee is a member reviews the proposed purchase or procurement for determination, the Employee also must recuse themselves from the review process.
Gifts Designated for the Benefit of a Named Investigator’s Scholarship or Research
1. Who: Business managers and employees of Sponsored Program Services (SPS) who receive notice of a gift for a faculty member or other named Investigator in their unit for which they have identified a business or pecuniary tie between the named faculty member/Investigator and the donor. This includes a gift to support a faculty member that is given by the faculty member, the faculty member’s Dependent or parent, and/or an entity in which the faculty member (or Dependent or parent) has a financial interest.
2. What: Notify the COI Officer of the nature of these ties.
3. When: Prior to obtaining any approvals for accepting the gift.
Sponsored Projects
1. Who: PIs and Investigators (see definition in policy) on project proposals submitted to external sponsors. PIs must identify when they submit the proposal to SPS all individuals who will be Investigators for the project.
2. What: Disclose Significant Financial Interests held by them and/or their Dependent(s) that are associated with the proposed project or their Institutional Responsibilities. For proposals to U.S. federal sponsors, this includes participation in any Foreign Talent Recruitment Program. For proposals to a Specified Sponsor, a Significant Financial Interest includes travel reimbursed or sponsored by certain third parties (see the definitions of Foreign Talent Recruitment Program and Significant Financial Interest).
  1. PIs and Investigators who are Purdue employees submit the disclosure via the Proposal-Driven Disclosure application.
  2. Investigators who are not Purdue employees submit the disclosure by emailing a completed Significant Financial Interest Disclosure Form for External Investigators (PDF) to fcoi@purdue.edu. If the proposal is to a Specified Sponsor, a completed Travel Disclosure Form for External Investigators (PDF) also must be attached to the email.
3. When: Disclosures must be made as soon as possible after receiving the email notification to do so and before submission of the proposal to the external sponsor.
Research Involving Human or Living Vertebrate Animal Subjects
1. Who: PIs, Senior/Key Personnel and Investigators (see definitions in policy) on protocol applications submitted to the Purdue University Human Research Protection Program (HRPP) for review and approval of research involving human subjects or to the Purdue University Animal Care and Use Committee (PACUC) for research, teaching or testing involving living vertebrate animals. PIs must identify when they submit the protocol all individuals who will be Investigators or Senior/Key Personnel for the project.
2. What: Disclose Significant Financial Interests held by them and/or their Dependent(s) that are associated with the outcome of the proposed research or in any entity that will be impacted by the outcome of the proposed research.
  1. Investigators who are Employees use the Proposal-Driven Disclosure application.
  2. Investigators who are not Employees, email a completed Significant Financial Interest Disclosure Form for External Investigators (PDF) to fcoi@purdue.edu.
3. When: In accordance with timelines established by the HRPP or PACUC for the submission of protocol applications.
Regulatory Committees
1. Who: Members of a Regulatory Committee who have a Financial Interest either in a protocol that will be reviewed by the committee or in an entity that may be affected by the outcome of the research project(s) utilizing the protocol to be reviewed.
2. What: Inform the chairperson of the Regulatory Committee that they are recusing themselves from participation in the review of the protocol because of a Financial Interest and return all materials associated with the protocol. The member must leave the room during committee discussions, deliberations and voting on the protocol, whether for initial review, continuing review, unexpected or adverse events, or non-compliance issues.
3. When: Notification to the chairperson must be given prior to the start of the protocol review. The member must leave the room prior to any discussion associated with the protocol as listed above.
Intellectual Property Commercialization
1. Who: Employees who hold an Equity Interest in, serve as an officer for or are involved in a management role with a third party to which OTC is considering licensing University intellectual property.
2. What: Provide information to the Responsible Official as requested in order to answer the following questions.
  1. Has the Employee received permission under the Conflicts of Commitment and Reportable Outside Activities policy (III.B.1) to engage in an outside activity with the third party named in license negotiations with OTC?
  2. Will the Employee be involved in continuing research and development of the licensed Purdue intellectual property in their capacity as an Employee (for example, through sponsored research funded by the licensee to Purdue University)?
  3. Will Purdue facilities be utilized for the licensee’s further commercial development of the licensed intellectual property?
  4. Will any Purdue trainee (for example, graduate student or postdoctoral researcher) be involved in further development at Purdue of the licensed intellectual property?
  5. Does the Employee plan to describe results from further development of the licensed intellectual property at Purdue in scholarly publications?
3. When: Above information needs to be provided by the Employee prior to any negotiations or agreements for licensing of the intellectual property to a third party and upon request from the Responsible Official.

Review of Disclosures

University Contracts, Purchases and Procurement
1. Upon receipt of a Conflict of Interest Disclosure Statement, the COI Officer will first determine whether the financial disclosure is necessary under policy III.B.2. Disclosures found to be unnecessary will be returned to the Employee.
2. The COI Officer will review necessary disclosures for completeness and to determine whether it is a new disclosure or a renewal of a previous disclosure. The COI Officer also will determine whether a disclosure under the policy on Conflicts of Commitment and Reportable Outside Activities (III.B.1) may be necessary and, if so, will confirm with the OA Officer whether one has been made and approved.
3. New Disclosures: The COI Officer will determine whether there is a Financial Conflict of Interest. If not, the COI Officer will forward all necessary documentation to the VPEC. If there is a Financial Conflict of Interest, the COI Officer will consider whether the conflict could be managed by the University.
  1. For a manageable conflict, the COI Officer will develop a written conflict management plan with the Employee and the appropriate oversight manager(s). Once the plan has been established and accepted, the COI Officer will forward all necessary documentation related to the disclosure to the VPEC.
  2. For a conflict that is unmanageable or inappropriate to manage, steps will be taken to eliminate the Financial Conflict of Interest, which may include blocking execution of the University transaction that is the subject of the Financial Interest or changing the Employee’s role and/or responsibilities. If, after the Financial Conflict of Interest has been eliminated, it is still possible and desirable to complete the University transaction, the COI Officer will forward all necessary documentation to the VPEC.
4. Renewal Disclosures: The COI Officer will determine whether elements of the disclosure or associated University transaction have changed such that the original disposition of the disclosure should be reconsidered. If there is no significant change, the COI Officer will forward all necessary documentation to the VPEC. If there is a significant change, the disclosure will be reviewed as a new disclosure under 1.C above.
5. Upon receipt of documentation from the COI Officer, the VPEC will submit the disclosure for review and approval at the next scheduled public meeting of the Board of Trustees. Once approved, the CFO will transmit the information to the Indiana State Board of Accounts.
6. At any point, if the COI Officer determines that a disclosed Financial Interest may be related to a sponsored project, the COI Officer will notify the Responsible Official (or designee), and the steps under section 3 (Sponsored Projects) below will be followed.
Gifts Designated for the Benefit of a Named Investigator’s Scholarship or Research
1. Upon receiving notice from a business manager or employee of SPS of a business or pecuniary tie between a named Investigator and a donor, as described in 1.A of the section on Submitting Disclosures, the COI Officer will:
2. Determine whether a disclosure under the policy on Conflicts of Commitment and Reportable Outside Activities (III.B.1) may be necessary and, if so, will confirm with the OA Officer whether one has been made and approved, and
3. Develop, with the Investigator and the proposed oversight manager, a management plan specifying how the gift will be managed and how the plan will be monitored.
4. The management plan will be forwarded with the gift information for approval by all administrative levels specified in the operating procedures that support the policy on Charitable Donations to the University (II.B.2).
  1. If approved at all administrative levels, the gift will be accepted and the management plan implemented.
  2. If the management plan is not approved at all administrative levels, the COI Officer will revise the management plan to address any concerns. Once the revised management plan has been accepted by the Investigator and oversight manager and approved at all administrative levels, the gift will be accepted and the management plan implemented.
Sponsored Projects
1. Upon receipt from the PI of the proposal and list of Investigators, SPS will alert the PI and each Investigator identified of the need to disclose Significant Financial Interests. If the proposal is being submitted to a Specified Sponsor, SPS also will remind the PI/Investigators of their responsibility to complete training as required by policy III.B.2 prior to expending sponsor funds in the event that the award is received. SPS also will ensure that any Specified Sponsor-related applications contain the appropriate certification regarding this policy, as required by regulations.
2. Upon receipt of a completed disclosure of Significant Financial Interest, the Responsible Official (or designee) will do one of the following:
  1. If the Investigator indicated they do not have a Significant Financial Interest, the proposal record will be updated to indicate that a disclosure has been submitted.
  2. If the Investigator indicated they do have a Significant Financial Interest, the proposal record will be updated to indicate that a disclosure has been submitted and the Responsible Official will determine whether the disclosure is necessary under policy III.B.2 and whether it is a new disclosure or an expansion of a previous disclosure. The Investigator will be informed of a disclosure that is unnecessary. The Responsible Official also will determine whether a disclosure under the policy on Conflicts of Commitment and Reportable Outside Activities (III.B.1) may be necessary and, if so, will confirm with the OA Officer whether one has been made and approved.
3. New Disclosures: The Responsible Official will determine whether the disclosed Significant Financial Interest will create a Financial Conflict of Interest if the proposed project is initiated. The Responsible Official will request the Research Security Office make a determination on any disclosures of Foreign Talent Recruitment Programs. If no Financial Conflict of Interest is identified, the Responsible Official will record the basis for this determination. If a Financial Conflict of Interest is identified, the Responsible Official will determine whether it can and should be managed by the University.
  1. If the Financial Conflict of Interest is judged to be unmanageable or inappropriate to manage, steps will be taken to eliminate the Financial Conflict of Interest, which may include withdrawing the project proposal that is the subject of the Financial Interest or changing the Investigator’s role and/or responsibilities in the proposed project. If, after the Financial Conflict of Interest has been eliminated, it is still possible and desirable to conduct the proposed project, the Responsible Official will record the actions taken to eliminate the Financial Conflict of Interest.
  2. If the Financial Conflict of Interest is judged to be manageable, a written conflict management plan will be developed with the Investigator and appropriate oversight manager(s). Once a management plan has been established and accepted, the Responsible Official will record the determination of a Financial Conflict of Interest and management plan. When the project is initiated, the management plan will be implemented and monitored. If the project is a funded by a Specified Sponsor, the Responsible Official will ensure that, prior to the University’s expenditure of any funds, notification is made to the awarding entity and a Financial Conflict of Interest Form is provided to the awarding entity.
4. Previous Disclosures: The Responsible Official will determine whether any aspect of the disclosure has changed that would require the original disposition of the disclosure to be reconsidered.
  1. If there is no significant change, the Responsible Official will record this conclusion and any previous actions taken. When the project is initiated, any necessary management plans previously developed will be implemented.
  2. If a significant change is identified, the disclosure will be re-reviewed as a new disclosure under Section 3.C above.
5. At any point, if the Responsible Official determines that a disclosed Significant Financial Interest may be related to a University contract, purchase or procurement, the Responsible Official will notify the COI Officer, and the steps under section 2.A above will be followed.
6. Any management plan for recognized Financial Conflicts of Interest will be implemented and monitored no less than annually by the office of the Responsible Official.
7. If a proposed project is funded by an external sponsor, the Responsible Official will execute whatever notifications of the sponsor and/or public disclosure or public access to information are required based on the sponsor’s terms and conditions for award. In the case of a proposal to and/or an award received from a Specified Sponsor, such public accessibility will (i) be made prior to the expenditure of awarded funds, (ii) include any identified Financial Conflicts of Interest held by Senior/Key Personnel and (iii) remain accessible for three years from the date the information was most recently updated.
8. In the event that a proposal is awarded by the sponsor, SPS will verify that all Investigators have submitted the appropriate form(s) and that any identified Financial Conflicts of Interest have been eliminated or managed. For project awards from a Specified Sponsor, SPS also will verify that the appropriate certification was made on the application and that all Investigators have completed the required training prior to releasing project funds. In the event that the required certification was not made, an identified Financial Conflict of Interest has not been managed or an Investigator’s training is not up to date, SPS will notify the Responsible Official. The Responsible Official (or designee) will contact the relevant Investigators to remedy the deficiency.
9. In the event a subgrant or subcontract will be executed in relation to a sponsored project, the Responsible Official and SPS will collaborate to ensure all appropriate terms and conditions for compliance with this policy and applicable laws, regulations and sponsoring agency requirements are included in the subgrant agreements or subcontracts. The Responsible Official and SPS also will see that appropriate systems and oversight are in place to monitor subrecipient compliance with policy III.B.2.
10. If it is determined that an Investigator has failed to disclose or update a disclosure of Significant Financial Interests as required by policy (III.B.2) or where it is discovered that an identified Financial Conflict of Interest has not been properly reviewed or managed, the Responsible Official will complete and document a retrospective review to identify real or potential bias within 120 days of the University’s determination of noncompliance. The retrospective review must contain all elements of information required by the Specified Sponsor.
  1. If bias is found, the Responsible Official will develop and submit to the sponsor a mitigation report, if required by regulation or project terms and conditions. The Responsible Official will recommend any appropriate administrative actions or sanctions that might be needed to ensure ongoing compliance.
  2. If the Investigator’s failure to comply with policy (III.B.2) appears to have biased the design, conduct or reporting of any research funded by a Specified Sponsor, the Responsible Official will notify the awarding entity of any corrective action taken or to be taken.
  3. In the event the U.S. Department of Health and Human Sciences determines that a PHS-funded clinical research project related to evaluating the safety or effectiveness of a drug, medical device or treatment with a Financial Conflict of Interest has not been managed or disclosed, the Investigator will be required to disclose the Financial Conflict of Interest in each public presentation of the results and request an addendum to any previously published presentations.
11. All disclosures and related documentation will be stored in a secure location and retained for a minimum of three years, or longer if required by applicable law or another University policy.
Research Involving Human or Living Vertebrate Animal Subjects
1. Upon receipt of a completed disclosure of Significant Financial Interest, the Responsible Official (or designee) will follow the steps outlined in section 3 (Sponsored Projects) above.
2. The Responsible Official will provide to the Human Research Protection Program (HRPP) at least twice per year (every six months) a list of all identified Financial Conflicts of Interest. When a protocol is submitted to the Institutional Review Board (IRB) for review, responsible staff will cross-reference with that list.
3. In the event that one or more Senior/Key Personnel or Investigators named in the protocol has a Financial Conflict of Interest, the IRB will request from the Responsible Official all information pertaining to whether and how the conflict was managed, reduced or eliminated and any approved management plan implemented to include in the review process. The IRB has the final authority to determine whether the conflict has been sufficiently managed, reduced or eliminated to allow the protocol to be approved.
4. Any management plan implemented in conjunction with a research protocol will be monitored no less frequently than annually by the office of the Responsible Official.
5. If a conflict is deemed unmanageable or inappropriate to manage, the IRB will recuse itself and defer the protocol for review to an appropriately qualified external and independent IRB.
6. Records related to disclosures of Financial Interests and Significant Financial Interests associated with IRB protocols will be maintained with the IRB protocol record for at least three years from completion of the research.
Intellectual Property Commercialization
1. Based on the information received from the Employee, the Responsible Official will determine whether a Financial Conflict of Interest management plan is required to oversee the Employee’s Institutional Responsibilities concerning the licensed intellectual property. If no management plan is needed, the Responsible Official will document the basis for this decision, file the documentation in a secure location and inform OTC that negotiations regarding licensing intellectual property to the third party may be completed.
2. If a management plan is needed, the Responsible Official will determine whether there is an existing management plan addressing a previously disclosed Financial Interest/Significant Financial Interest related to this third party.
  1. If no relevant management plan exists, one will be developed with the Employee and appropriate oversight manager, which will then be implemented and monitored by the office of the Responsible Official. The Responsible Official will notify the cognizant dean or unit leader of the implementation of the plan and will notify OTC that negotiations regarding licensing intellectual property to this third party may be completed.
  2. In the event that a management plan acceptable to all parties cannot be developed, the Employee, the Employee’s dean or unit leader and OTC will be informed by the office of the Responsible Official that negotiations regarding licensing intellectual property to this third party may not be executed until or unless a mutually acceptable management plan is accepted.
  3. If a relevant management plan already exists, the existing management plan will be reviewed to determine whether it addresses issues related to the potential license of University intellectual property to the third party. If it does, the office of the Responsible Official will notify the cognizant dean and OTC that negotiations regarding licensing intellectual property to this third party may be completed. If the existing management plan does not address all relevant issues, it will be revised as described for a new management plan in 5.B.1 & 2 above.

Notices to Employees

University Contracts, Purchases and Procurement
1. Prior to the beginning of each fiscal year, the VPEC will remind all Employees of the obligation to disclose any and all Financial Interests held by them and/or their Dependents in University purchases or procurement of goods or services, contracts, investments and/or loans. The reminder notice also will:
  1. Describe the necessity of updating financial disclosures or submitting new financial disclosures during the year if new or altered Financial Interests develop.
  2. Remind Employees that a disclosure related to a Financial Interest in any University purchase or procurement of goods or services, or in any investment or loan made by the University, must be made as far in advance of the purchase, procurement, investment or loan as possible to provide sufficient time for the COI Officer to obtain approval of the disclosure in a public meeting of the Board of Trustees before final action is taken on the purchase, contract, investment or loan, as required by state law.
2. The COI Officer, in consultation with appropriate University human resources staff and other officials, will develop a process to notify new Employees of their obligation to complete a disclosure form for each of their existing and known Financial Interests.
Sponsored Projects
1. Annually, the Responsible Official will provide a written notice to all Investigators who have filed disclosure forms associated with pending proposals and/or funded projects, whether they initially indicated a Significant Financial Interest or not, of the need to update their disclosure.
2. For sponsored project awards from a Specified Sponsor, the office of the Responsible Official will further provide, at least annually, a written reminder to all Investigators of the requirement to identify additional Investigators and/or Senior/Key Personnel added to the project and/or identified in a report to a Specified Sponsor, and to update disclosures of Significant Financial Interest within 30 days of discovering or acquiring (e.g., through purchase, marriage or inheritance) a new Significant Financial Interest or engaging in travel reimbursed or sponsored by a third party (other than by the Investigator’s employer). If additional Investigators and/or Senior/Key Personnel are identified, the Responsible Official (or designee) will contact these added individuals to solicit disclosure forms and, upon receipt of such forms, follow the appropriate steps as outlined in these procedures.

Training Requirements

Upon initial submission of an IRB protocol and at least every four years thereafter, Senior/Key Personnel must complete training on the conduct of human subjects research, including responsibilities for disclosures of related Financial Interests and Significant Financial Interests. This training will be incorporated into other required training for research with human subjects. Training is required to be completed promptly upon
1. Any revision to policy III.B.2 that changes the responsibilities for Senior/Key Personnel,
2. When Senior/Key Personnel new to Purdue University apply for exemption or approval from the IRB, and
3. If a researcher identified as Senior/Key Personnel is non-compliant with policy III.B.2 or these procedures.

Investigators on Research Projects Funded by a Specified Sponsor must comply with training requirements established by the Responsible Official to satisfy requirements of the sponsor’s policy.
Records of training will be maintained for at least three years after the completion of a research project.

Appeals

Employees or Investigators who disagree with a decision regarding the existence of a Financial Conflict of Interest or the necessary elements of a conflict management plan may submit a written appeal to the COI Officer. The COI Officer will submit the appeal to the VPEC, who will convene and ad hoc appeals committee for review. The decision of the committee on the matter will be final for all purposes.

History and Updates

January 8, 2024: Updated item 3 of the Submitting Disclosures section to include mention of Foreign Talent Recruitment Programs.

April 1, 2023: Added Appendix A and included references to Specified Sponsors throughout as applicable.

January 1, 2019: Procedures were separated from the policy on Individual Financial Conflicts of Interest (III.B.2). The procedures have been reformatted to make them easier to understand and updates have been made to align them with current practices.

APPENDIX A: SPECIFIED SPONSORS

Public Health Services (PHS) Agencies

Agency for Health Care Research & Quality (AHRQ)
Agency for Toxic Substances and Disease Registry (ATSDR)
Centers for Disease Control and Prevention (CDC)
Food and Drug Administration (FDA)
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National Institutes of Health (NIH)
Office of Global Affairs (OG)
Office of Public Health and Science
Office of the Assistant Secretary for Health (OASH)
Office of the Assistant Secretary for Planning and Evaluation
Office of the Assistant Secretary for Preparedness and Response (ASPR)
Substance Abuse and Mental Health Services Administration (SAMHSA)

PHS-Like Agencies (agencies that adopted the PHS FCOI regulations)

Alliance for Lupus Research (ALR)
American Asthma Foundation
American Cancer Society (ACS)
American Heart Association (AHA)
American Lung Association (ALA)
Arthritis Foundation (AF)
CurePSP
Juvenile Diabetes Research Foundation (JDRF)
Lupus Foundation of America (LFA)
Patient-Centered Outcomes Research Institute (PCORI)
Susan G. Komen for the Cure
United Soybean Alliance
Administration for Children and Families (ACF)

Other Specified Sponsors

National Aeronautics and Space Administration (NASA)
National Science Foundation (NSF)
U.S. Department of Energy (DOE), its agencies and national laboratories